Tonix Pharmaceuticals Revealed Data On TONMYATM At The 2026 American Academy of Pain Medicine PainConnect Annual Meeting, in Salt Lake City, Utah; Treatment With TONMYA Provided Statistically Significant Pain Reduction In Two Phase 3 Trials And Was Generally Well Tolerated

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, presented data on TONMYATM (cyclobenzaprine HCl sublingual tablets), at the 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, in Salt Lake City, Utah.

"The data presented at the AAPM PainConnect Annual Meeting support TONMYA's role as a safe and effective non-opioid analgesic for daily use at bedtime in fibromyalgia,1,2" said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. "TONMYA is designed to target nonrestorative sleep and is a first-in-class tertiary amine tricyclic for long-term use. As the first approved therapy for fibromyalgia in over 15 years, TONMYA is an alternative to three currently FDA-approved medicines, which are limited by side effects, adherence, and high discontinuation rates. TONMYA's unique sublingual formulation enables cyclobenzaprine to bypass first-pass hepatic metabolism. Relative to off-label oral swallowed cyclobenzaprine, TONMYA treatment results in reduced formation of the active, persistent metabolite norcyclobenzaprine, which we believe interferes with the durability of cyclobenzaprine's treatment effect in fibromyalgia with long term dosing. Oral cyclobenzaprine failed in development because it provided only short-term (one month) benefit3, which is not sufficient for the treatment of fibromyalgia, a chronic condition that requires a sustained treatment effect."

Data presented at the AAPM PainConnect Annual Meeting are from the Phase 3 RESILIENT trial, a 14-week randomized, double-blind, placebo-controlled study that assessed the safety and efficacy of TONMYA in 457 patients who met the 2016 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia. In addition to showing a statistically significant reduction in mean daily pain at 14 weeks, TONMYA treatment resulted in an increase over placebo in the number of individuals with a 30% reduction in daily pain, which is considered a clinically meaningful response. The most common adverse events were mild and self-limited oral cavity reactions that uncommonly led to study withdrawal. TONMYA was approved by the FDA in August 2025 in part based on the Phase 3 RESILIENT trial results and was commercially launched in the U.S. in November 2025.